The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source, Model Ls-200.
| Device ID | K091962 |
| 510k Number | K091962 |
| Device Name: | POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 |
| Classification | Mini Endoscope, Gastroenterology-urology |
| Applicant | LUMENIS, INC. 5302 BETSY ROSS RD, Santa Clara, CA 95054 |
| Contact | Mike Aymami |
| Correspondent | Mike Aymami LUMENIS, INC. 5302 BETSY ROSS RD, Santa Clara, CA 95054 |
| Product Code | ODF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-01 |
| Decision Date | 2009-09-30 |
| Summary: | summary |